inforMED
MalfunctionEIE

HYGENIC

Received Aug 23, 2018 · Event occurred Jun 4, 2018

Report 2416455-2018-08237 · MDR key 7808692

Device

Generic name

Dental Dam

Catalog number

H11627

Lot number

160J7

Product problems

  • Material Integrity Problem
  • Material Split, Cut or Torn
  • Material Integrity Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Known Impact Or Consequence To Patient
  • No Consequences Or Impact To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DENTAL DAM TORE IN PATIENTS MOUTH AFTER GETTING WET.

Remedial action

  • Replace